Health Care Job Information Sheet #20. Clinical Research

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1 Health Care Job Information Sheet #20 Clinical Research A. Background B. Occupations 1) Clinical Research Associate (Study Monitor) 2) Clinical Research Coordinator 3) Other positions in the field C. Labour Market Prospects D. ITPs in the Field E. Links A. Background What is a clinical trial? Source: When a drug manufacturer applies to have a new drug approved for sale in Canada, it is expected to show scientific evidence of the drug's safety, efficacy and quality in humans. While the effects of a new drug on people can be measured in other ways -- such as astute observation or anecdotal evidence - a clinical trial is the best scientific approach to providing clear and reliable data. Specifically, a clinical trial is used to determine whether a drug is safe and effective, what dosages are most effective, and what side effects a drug may cause in people. In a controlled clinical trial, comparable groups of people receive different forms of treatments. One group may receive the drug being tested, while another group may receive a treatment already known to be effective, or a placebo (an inactive substance that looks like the drug being tested). Once the trial is complete, the outcomes of the separate groups are compared and analysed to determine the effect of the drug. Who regulates clinical trials? Who runs them? Source: Clinical trials in Canada are most often cooperative projects undertaken by many players including the drug industry, research granting councils, the medical community, the ethics community and the federal government. When a sponsor -- generally a pharmaceutical company -- wants to conduct a clinical trial in Canada, it must apply to Health Canada. Applicants must submit a "protocol" that outlines the objectives, methods and rules by which they will function during the trial. They must also justify that a clinical trial is worth whatever potential risks the drug might have and that the patients will not be exposed to undue risk. Health Canada reviews the application to make sure all the necessary components have been included in the trial and that the scientific methods are sound. The application is also reviewed by an independent research ethics board, for example a hospital review board, that examines the protocols. It is the researcher's responsibility to maintain the protocols and gather the data. Different types of clinical trials Clinical trials are normally done in four phases, each successive phase involving a larger number of people. Phase one studies, often referred to as "first in humans studies", are primarily concerned with assessing the drug's safety. Testing is usually done in a small number of healthy volunteers, who are usually paid for participating in the study. Phase one trials may be conducted in patients when administration of the drug to healthy volunteers is not ethical.

2 Once a drug has been shown to be safe, it is then tested for efficacy in a phase two study. Phase two trials involve several hundred patients. The patients are usually separated into two groups, which are randomized so that they are as similar as possible in age, gender distribution, and medical history. One group of patients then receives the experimental drug, while a second "control" group receives standard treatment or a placebo. Often these studies are "blinded", so that the patient does not know which treatment he or she is receiving. "Double blinded" studies mean that neither the patient, nor the researchers know who is getting the treatment. This ensures that the data collected will not be affected by the bias of a patient or researcher. Once the safety and efficacy of a particular drug has been shown, it is then tested on a much larger scale (several hundred to several thousand patients) in a phase three study, to give researchers a more thorough understanding of the drug's efficacy, benefits, and the range of possible negative reactions. Most phase three studies are randomized and blinded, lasting several years. After successfully completing phase three testing, the drug is ready to be reviewed for approval. Phase four trials are performed after the drug is on the market. These trials relate to the approved indication for the drug and are important for optimizing the drug's use. Acronyms GCPs: good clinical practices SOPs standard operating procedures CRFs : case report forms CRA: Clinical Research Associate CRC: Clinical Research Coordinator CRPs: Clinical Research Professionals ADR: Adverse Drug Reaction SAE: Serious Adverse Event CIHR: Canadian Institutes of Health Research (supervises clinical trials in Canada) B. Occupations 1) Clinical Research Associate (CRA) / Study Monitor Not a regulated profession in Ontario There are various levels of CRA s depending on years of experience (CRA 1, 2, 3) Role CRAs monitor investigational sites to ensure both the quality and timeliness of clinical data. They ensure that good clinical practices are followed, that the site complies with regulations and that the study s objectives are met. Duties may include; Monitoring data and conducting thorough source document verification, case report forms (CRFs) and physician records to see that patients are appropriately enrolled and studied, and to ensure that the data they re given matches the data on the patient s chart Checking to see that sites are complying with increasingly complex regulations Conducting onsite monitoring to verify the protection of participants, accuracy of reported trial data and ensure that the study is conducted in accordance with guidelines Selecting qualified investigators Obtaining and monitoring Informed consent Conducting adverse event and safety monitoring

6 Scientific, i.e., Biologists Chemists Research Scientists C) Labour Market Prospects Ontario is home to more than half of Canada s brand-name pharmaceutical and medical devices industries, and almost half of its medical biotechnology industry. Major pharmaceutical companies generate their revenues from a few key Brand Name products. When the patents expire on these products, other pharmaceutical companies may produce a generic drug based on the brand-name drug which will inevitably lead to a loss of profits. In the next few years, many key patents will expire and major pharmaceutical companies (i.e. Pfizer, Eli Lilly, Merck, Apotex, GlaxoSmithKline etc.) will be looking to bring new pharmaceutical products off the laboratory bench and onto the pharmacy shelves. In order to accommodate this, the pharmaceutical industry will transition from pre-clinical research and development ( R & D) to clinical trial work. As such, the industry will witness a demand for CRPs (Clinical Research Professionals). Source: Other factors at play at the same time are tightening regulatory scrutiny that results in slower processes and higher costs for companies. Corporations tend to respond to this with major structural and organizational changes such as mergers, downsizing and outsourcing to countries where labour costs are cheaper. D) ITPs in the Field Many ITPs have had clinical research experience during their university studies or in jobs hence have the knowledge of types of studies, common statistical tests, data sources and statistical analysis as well as having the skills to organize, implement, and conduct clinical trials Clinical research takes place in a medical setting; ITPS have the background to interact effectively in this setting ITPs already have considerable clinical training and background education in the sciences (anatomy, physiology, etc.) that provides them with much of the background knowledge necessary for specific research projects. Often ITPs who were specialists are hired for research positions related to their specialty (i.e., internist research on drugs for diabetics) In addition, research positions often require less command of the English language than other occupations. For example, maintaining databases and running experiments typically requires lower proficiency in English than occupations requiring direct patient contact.

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